Safety & PV Specialist I - PQC

Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding Safety & PV Specialist I - PQC Company: Syneos Health Location: Gurgaon, India Job ID: 25107950 Employment Type: Full-Time Work Mode: Office-Based Experience Required: 2.5 4 Years About Syneos Health Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company partners with innovators across the drug development and commercialization continuum, helping navigate complexity and accelerate progress. Syneos Health Focuses On: Clinical development solutions Medical affairs Commercial insights Patient-focused healthcare innovation Job Summary The Safety & Pharmacovigilance Specialist I Medical Device & PQC is responsible for: End-to-end Individual Case Safety Report (ICSR) processing Safety data management Regulatory reporting support Compliance with global pharmacovigilance regulations Product Quality Complaint (PQC) case handling Medical research-related safety case processing Key Responsibilities ICSR Processing & Case Management Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs. Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans. Triage ICSRs and evaluate Completeness Accuracy Regulatory reportability Enter case data into safety databases such as: Argus ARISg Perform coding of Adverse events Medical history Concomitant medications Laboratory tests Code using MedDRA Relevant medical dictionaries Prepare accurate medical narrative summaries. Identify missing or inconsistent information. Follow up on queries until resolution. Identify and manage duplicate ICSRs. Perform quality review of ICSRs. Regulatory Reporting & Compliance Support preparation and submission of expedited safety reports. Ensure reporting activities comply with global regulatory requirements. Validate and submit xEVMPD product records. Perform MedDRA coding of indication terms. Perform manual recoding of uncoded product and substance terms. Support SPOR / IDMP activities. Maintain safety tracking activities. Ensure documentation submission to Trial Master File (TMF) Pharmacovigilance System Master File (PSMF) Apply safety reporting regulatory intelligence. Maintain compliance with SOPs Work Instructions (WIs) GCP ICH guidelines GVP regulations Global drug, biologic, and device regulations Literature, Audit & Collaboration Perform literature screening and safety reviews. Maintain drug dictionaries. Support coding activities. Participate in audits and inspection readiness activities. Maintain professional relationships with: Internal teams External stakeholders Project partners Required Qualifications Education Eligible Qualifications: B.Pharm M.Pharm PharmD BDS BMS MBBS Not Eligible: B.Sc M.Sc Required Experience & Skills Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively. Experience handling medical research-related safety cases. Hands-on experience with: Argus safety database ARISg safety database Strong understanding of Pharmacovigilance regulations Safety reporting requirements Knowled .